JOB OVERVIEW: Provide leadership of the Crosstex Medical Division Quality Assurance Team. Lead quality assurance support to Manufacturing Operations by ensuring timely release of product, resolving quality related issues, improving product quality and investigating customer complaints. Utilize the Correction and Preventive Action system to pursue continuous improvement of the Crosstex Quality System and Crosstex products. Ensure quality assurance responsibilities are met by adhering to Quality System and having a thorough understanding of FDA and ISO 13485 regulations.
Lead and develop QA department, to ensure clear communication, meaningful employee development, and motivation.
Develop long and short-term plans projecting quality assurance programs and objectives.
Maintain compliance with FDA and ISO requirements. This includes being part of the team for FDA and ISO audits.
Oversee adherence to an effective corrective and preventive action (CAPA) system.
Oversee customer complaint investigations and ensure timely and effective closure of customer complaints.
Adhere to the cGMP and cGLP guidelines as well as the guidelines established by other regulatory bodies.
Direct cross-functional efforts to improve the quality system and assure suitability with all products.
Encourage a teamwork approach with Manufacturing, Research and Development, Engineering, Marketing and Sales and facilitate an atmosphere of prompt resolution to complex issues when they arise.
Proactively enhance the company's core technologies by developing quality plans, FMEA, and or test plans for new products.
Represent QA on new product and project teams.
Organize and schedule Quality Management Reviews as required by the Quality System.
BA or BS degree in a technical discipline, with a minimum of 5 years’ experience in a regulated industry is required.
Background in sterilization or biological indicators preferred but not required.
Must have a sound understanding of how to lead a multi discipline team.
Must have a sound understanding of manufacturing operations.
Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations.
Responsive and reliable, with exceptional follow-through.
Ability to work both independently and as a team player.
Crosstex International is a leading global manufacturer of infection control and prevention products for the healthcare market. We create high quality, innovative products, the majority of which are manufactured in the United States. Our broad range of products for multiple healthcare disciplines include: SecureFit® Face Masks, ConFirm® Sterilization Monitoring, SaniTyze™ Waterless Antimicrobial G...el and our Patients Choice ® line of preventive products. With ten manufacturing/distribution facilities around the world – 7 in the United States and 3 internationally – Crosstex services the global healthcare community in an efficient and timely manner.